Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13966 |
| Brand Name: | Waters Mass Spectrometers |
| Model: | 9 models |
| Affected: | All serial numbers |
| Software version: | |
| Recalling Organisation: | SciMed Ltd Unit 2, 1 Tussock Lane Ferrymead Christchurch 8023 |
| Contact Information: | 0800-724-633 |
| Manufacturer: | Waters Corporation |
| Issue: | The ion block source heater can fail, potentially leading to inaccurate results which may not be picked up by quality control or internal standard monitoring. Assays with shorter dwell times are most affected, including neonatal screening for phenylketonuria, medium chain acyl CoA dehydrogenase deficiency and maple syrup urine disease. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/2/2013 |
